Brusel žiada návrat lieku Diane 35 na francúzsky trh | Medicínske právo
              

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Brusel žiada návrat lieku Diane 35 na francúzsky trh


 | 7.8.2013 | komentárov: 287

Európska komisia adresovala utorok 30. júla Francúzsku žiadosť o opätovné zavedenie tabletiek Diane 35 na trh. Dôvodom ich stiahnutia v máji 2013 boli negatívne následky, ktoré môžu mať na zdravie pacientov.

Obrazok Francúzska lieková agentúra (l'Agence française du médicament, ANSM) odporučila ešte v januári zastaviť predaj tohto liečiva. Dôvodom boli štyri úmrtia zaznamenané v súvislosti s užívaním Diane 35. V máji bol už liek stiahnutý z predaja. Tento zákaz odmietla Koordinačná skupina pre vzájomné uznávanie a decentralizované postupy – humánne (CMDh), orgán EÚ zoskupujúci úrady pre liečivá z iných členských štátov. Európska komisia následne stanovila, že prínosy lieku Diane 35 prevyšujú jeho možné riziká v prípade, ak sa používa v presne stanovených indikáciách a rozhodla o jeho návrate na pulty francúzskych lekární. Toto rozhodnutie je záväzné pre všetky členské štáty, vrátane Slovenska. Laboratóriá Bayer, ktoré Diane 35 distribuujú na trh, toto rozhodnutie uvítali.

Vo Francúzsku sa liek Diane 35 nepoužíval v súlade so schválenými indikáciami. Tento liek proti akné bol predpisovaný najmä ako antikoncepčné tabletky. Debatu na tému rizík spojených s užívaním antikoncepcie spustila žaloba mladej ženy, obete mŕtvice, ktorej zapríčinenie sa pripisuje práve následkom antikoncepčných piluliek. Ochorenie, ktoré sa najčastejšie skloňuje v súvislosti s Diane 35 je možný vznik žilovej trombózy. Návrat Diane 35 do francúzskych lekární bude sprevádzaný množstvom obmedzení.

Obmedzenia sa dotknú predovšetkým predpisovania. Lekár už nebude môcť použiť tento medikament ako primárne riešenie liečby akné, ale len v prípade, ak sa klasická liečba alebo antibiotiká ukážu ako neúčinné. Ich predpísanie bude vylúčené u pacientov s kontraindikáciami, s predispozíciou žilovej trombózy alebo tých, ktorí túto chorobu už prekonali. Užívanie Diane 35 nebude možné kombinovať s iným druhom perorálnej antikoncepcie a ich predpísanie bude zakázané pri liečbe alopecie (vypadávania vlasov).
Európska komisia ďalej požaduje lepšiu informovanosť spotrebiteľa ako aj zdravotníckych odborníkov. Malo by sa tak stať zmenou príbalových letákov, v ktorých by mali figurovať informácie o kontraindikáciách. Diane 35 bude podliehať osobitnej kontrole. Do troch mesiacov má byť predstavený plán , ktorý bude sledovať možné riziká Diane 35.

Spracovala: Katarína Zubková
Foto: freedigitalphotos.net

Zdroje:
 http://lci.tf1.fr/science/sante/bruxelles-exige-que-la-france-remette-la-pilule-diane-35-sur-le-8235447.html
http://www.franceinfo.fr/sciences-sante/diane-35-bientot-de-retour-sur-le-marche-1087907-2013-07-30
http://www.leparisien.fr/societe/la-pilule-diane-35-bientot-de-retour-sur-le-marche-francais-30-07-201http://www.euractiv.fr/social/la-commission-europeenne-autorise-la-pilule-diane-35-en-france-20004.html
3-3018837.php




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